The ASM has a long history of supporting and informing public policy that is based on the essential principle of ensuring protection of public health and safety without unduly encumbering legitimate fundamental scientific research, clinical and diagnostic testing for the treatment and prevention of infectious diseases. The ASM has and continues to have a position that microbiological research must be done safely and in accordance with regulations governing the proper conduct of that research.

Recently, issues involving dual use research of concern and laboratory biosafety have intensified debate about the risk, safety, and ethical conduct of scientific inquiry related to microbiology. The ASM believes that the scientific community must confront each of these important issues. The focus of these conversations should be on assuring both safety and security in research and in the publication of research results from studies that are performed according to regulations. This must be done without compromising vital innovation or public health interests that are posed by unwarranted or unwise limitations of scientific inquiries or of the publication of research results.

Crucial research for the treatment, control and prevention of infectious diseases may require the utilization of pathogenic material and laboratory safety and security must be assured. The ASM recently sent its members an alert regarding biosafety in microbiology laboratories (http://www.asm.org/index.php/public-policy/93-policy/93014-biosafety-7-14). The ASM has also prepared a history of issues and policy related to biological research with select agents and toxins, high containment laboratories, dual use research of concern and gain-of-function (GOF) research. This document is posted on the ASM web site at (http://www.asm.org/images/PSAB/History-SelectAgents.pdf). We hope this document will help provide necessary background information that is needed to inform discussions.

The ASM recognizes the legitimacy of concerns in the debate over laboratory biosafety and oversight of dual use research of concern. Based on this, it supports reasonable, balanced, and sensible discussions that will lead to a consensus about the formulation of public policy that will not unduly restrict or encumber needed scientific research and that will ensure that the conduct of such research is protective of the health of humans, animals, plants, and the environment to the extent possible. The ASM agrees that we must enhance laboratory safety. At the same time, it is our position that we must avoid policies that unnecessarily or inadvertently inhibit scientific research and medical progress, thereby adversely affecting public health. There already are extensive regulations for the conduct of research on dangerous pathogens, including a specific policy for gain-of-function research on Highly Pathogenic Avian Influenza H5N1 Viruses that are Transmissible among Mammals by Respiratory Droplets. If these regulations and policy frameworks are inadequate they should be modified. The HHS/NIH should consult with the scientific community regarding the adequacy of the specific H5N1 oversight system as well as review the adequacy of regulations and guidance associated with research on microbial pathogens given that accidents occasionally will happen even in the best of laboratories.

Policies governing the safety of microbiological research should be subject to constant review and revision as needed. Any new policy measures for pathogens, microbiological laboratories and the conduct of research in the life science must be crafted with care and must not have a significantly adverse effect on critically important research activities. ASM urges a careful and prudent balancing of concern about risk, safety, security and the risk and potential impact of inadvertent release of potential pathogens with the need to conduct legitimate research and diagnostic testing that is vital to making new scientific discoveries and combatting infectious diseases. The ASM recommends that the National Academy of Sciences should be asked to consider whether the current scope of GOF research offers the benefits that merit taking the risks inherent in performing that research as well as the adequacy of the current oversight system for approval and safeguards required for the performance of such research.

ASM stands ready to assist in facilitating discussions and policy development. Research advances against infectious diseases has benefited society as much or even more than any other achievement of medical science.